Orthalign, Inc: Orthopedic Stereotaxic Instrument
Recall Summary Orthalign, Inc is recalling certain Drill Plate components (model Ortho Dev. Trimax - Pegged, PREF Size 6-7, REF 402567) used in knee surgery systems nationwide. Some of these drill plates were manufactured outside of specifications and may cause larger bone cuts than intended during surgery. This is a Class II recall affecting medical facilities across the United States.
- Recalling firm
- Orthalign, Inc
- Product
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
- Reason
- Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the state of UT.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e99620ea-efdf-41f2-89a8-0c2b717babc7